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Terminated

Bucky Diagnost FS Part number 9890-010-83651

FDA Recall Z-0268-04 · Posted 2003-12-24

Recalling FirmPhilips Medical Systems Sales & Service Region No. America
Recall StatusTerminated
Product CodeKPR
Date Initiated2003-11-18
Date Terminated2005-04-11
Product Quantity3 units

Reason for Recall

Support chain attachment on the Bucky carriage may fail and cause the counter weights or X-ray tube to fall.

Firm Action

The firm mailed a letter to their customers on November 18, 2003 stating upgrades will begin November 14, 2003.

Root Cause

Other

Distribution Pattern

The firm distributed to three medical facilities in Florida, New York and California.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K945278PHILIPS BUCKY DIAGNOST FAMILYPhilips Medical Systems North America, Inc. · 1994-12-14

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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